The products are for patients over the age of 18 who are critically ill and in intensive care, immobile or immobilised patients and/or in some cases mobile patients with persistent diarrhea.
Conditions
Interventions
Group 1: The mentioned parameters of the observation are documented within a CRF.
Sponsors
Advanced Medical Balloons GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Indication for an IFMS: drainage of liquid or semi-liquid stool 2. Age = 18 years 3. Patient is expected to remain with IFMS treatment for a minimum of 48 h 4. Written informed consent 5. Insertion of the drainage possible
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity of patient to IFMS product components (polyvinyl chloride, polyurethane, silicone, polycarbonate) 2. Anatomical contraindications for IFMS use (severe rectal/anal strictures, or tumors of unclear origin) 3. Medical contraindications for IFMS use (rectal/anal bleeding, rectal/anal injuries, diseases of the rectal mucosa (i.e., proctitis, ischemic proctitis, mucosal macerations), no/insufficient tone of the anal sphincter, a gaping/open sphincter, colorectal surgery within the last 6 months) 4. Participation in another (non)interventional study or observation period of a competing study 5. Staying in a facility due to a legal or official order
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recording of the sealing efficiency based on the nursing shift using a predefined range. | — |
Secondary
| Measure | Time frame |
|---|---|
| Daily assessment of anal lesions. Daily assessment of the perianal skin status. | — |
Countries
Germany
Contacts
Public ContactTobias Gutting
Universitätsklinikum Heidelberg Innere Medizin IV
Outcome results
None listed